SEC Filing - Delcath Systems, Inc.

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UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 9, 2004 DELCATH SYSTEMS, INC. (Exact name of registrant as specified in its charter) Delaware 001-16133 06-1245881 (State or other (Commission File Number) (IRS Employer jurisdiction of Identification No.) incorporation) 1100 Summer Street, Stamford, Connecticut 06905 (Address of principal executive offices and zip code) Registrant's telephone number, including area code: (203) 323-8668 N/A (Former name or former address, if changes since last report)

2 Item 5. Other Events and Regulation FD Disclosure On March 9, 2004, Delicate Systems, Inc. (the "Company") issued a press release relating to the enrollment of the first patient in its Phase III clinical trial for inoperable cancer in the liver Company's press release dated March 9, 2004 is incorporated herein by reference and filed as an exhibit hereto. Item 7. Financial Statements and Exhibits. (a) Not applicable (b) Not applicable. (c) Exhibits: Exhibit Description ------- ----------- 99 Press Release dated March 9, 2004 of Delcath Systems, Inc.

3 SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. DELCATH SYSTEMS, INC. By: /s/ M. S. KOLY ---------------------- M. S. Koly President and Chief Executive Officer Date: March 9, 2004

EXHIBIT INDEX Exhibit Description ------- ----------- 99 Press Release dated March 9, 2004 of Delcath Systems, Inc.

Release Date: Immediate Contact: M.S. Koly Thomas Redington Chief Executive Officer Redington, Inc. Delcath Systems, Inc. 203/222-7399 203/323-8668 212/926-1733 www.delcath.com www.redingtoninc.com FIRST PATIENT ACCEPTED IN DELCATH PHASE III LIVER CANCER STUDY STAMFORD, CT MAR. 9 - Delcath Systems, Inc. (Nasdaq: DCTH) said the first patient has been accepted for enrollment in its Phase III clinical trial for inoperable cancer in the liver. The patient will be treated at the Sydney Melanoma Unit at the Royal Price Alfred Hospital in Sydney, Australia, the initial clinical site for the company's pivotal trial. "This is an important milestone for our company and marks the beginning of our final step toward FDA approval," said M.S. Koly, CEO of Delcath. "Now that the first patient is enrolled, the clinical team in Sydney indicated to us that future enrollments should happen at a more rapid pace." Delcath is undertaking the Phase III pivotal trial for FDA approval to commercialize its isolated liver perfusion system for delivery of high dose chemotherapy directly to the liver via the hepatic artery. The FDA-approved protocol calls for enrolling 122 patients (including 61 controls) to determine whether patients treated with Delcath's system experience statistically longer survival versus the control group. The Delcath system uses special catheters and filters to direct and trap toxic anticancer chemicals, so they can be delivered in high doses to the liver while protecting the rest of the body from excessive toxicity. The Phase III study is testing the drug doxorubicin in patients with melanoma metastasized to the liver. Omnicare, Inc. (NYSE: OCR), a global contract research organization with 29 principal offices and a presence in 27 countries, is managing the trial on behalf of Delcath. The principal investigator of the Sydney study is John Thompson, MD, Director of the Sydney Melanoma Unit at the Royal Price Alfred Hospital and professor of surgery (melanoma and surgical oncology) at the University of Sydney. He is a world leader in the development of perfusion and infusion therapies for regional treatment of recurrent melanoma. The Sydney Melanoma Unit has accumulated the largest database of melanoma patients in the world. It has treated more than 15,000 -more-

melanoma patients since its inception in 1968 and sees approximately 750 new melanoma patients yearly. Delcath is a developer of isolated perfusion technology for organ or region-specific delivery of therapeutic agents. Six US, and three foreign issued patents cover its technology. The company is headquartered in Stamford, CT. # # # This release contains "forward-looking statements" based on current expectations but involving known and unknown risks and uncertainties. Actual results or achievements may be materially different from those expressed or implied. Delcath plans and objectives are based on assumptions involving judgments with respect to future economic, competitive and market conditions, its ability to consummate, and the timing of, acquisitions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond its control. Therefore, there can be no assurance than any forward-looking statement will prove to be accurate.